Z-1333-06

Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17...

Name: Z-1333-06 Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17...
Creator: Pointe Scientific, Inc.
Published: 2006-06-07
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2006-06-07 / Terminated / root cause: labeling and UDI

FDA source

Pointe Scientific, Inc. began a recall of Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300 on 2006-06-07. The reason FDA records is "Product does not meet performance specifications through its labeled expiration period". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1333-06
Status: Terminated
Initiated: 2006-06-07
Posted: 2006-08-03
Terminated: 2007-11-19
Recalling firm: Horiba Instruments Incorporated
Product: Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300.
Product code: CFR Hexokinase, Glucose
Reason for recall: Product does not meet performance specifications through its labeled expiration period.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.
Quantity in commerce: 279 bottles
Distribution: Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
Product codes and lots: Lots 431704, 511901 and 525101.

Product code CFR

K002199Class IIModification to Liquid Glucose (Hexokinase) Reagent SetPointe Scientific, Inc., / cleared 2000-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)